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Phase 1/2 Study of Respiratory Syncytial Virus and Human Metapneumovirus (RSV+HMPV) Vaccine Candidate in Adults 60 Years of Age and Older
Sponsor: Sanofi
Summary
This study is a Phase 1/2, randomized, observer-blind, active and placebo-controlled, multi-center study to be conducted in approximately 2400 adults 60 years of age and older. The aim of the study is to evaluate the immunogenicity and safety of an RSV+HMPV vaccine candidate for the prevention of RSV and HMPV disease among adults 60 years of age and older. While there are 3 FDA approved/licensed RSV vaccines currently available to the public, no vaccine is available for the prevention of HMPV in older adults. This study is intended to provide data in support of further clinical development of the RSV+HMPV vaccine candidate. The study will consist of 4 cohorts and 11 vaccine groups (RSV+HMPV \[6 dose levels\], placebo and 4 control groups). The duration of the study will be approximately 12 months for each participant.
Official title: A Phase 1/2, Randomized, Controlled, Observer-Blind Study in Adults 60 Years of Age and Older to Evaluate the Immunogenicity and Safety of Different Dose Levels of a Bivalent Vaccine Candidate Against Respiratory Syncytial Virus (RSV) and Human Metapneumovirus (HMPV)
Key Details
Gender
All
Age Range
60 Years - Any
Study Type
INTERVENTIONAL
Enrollment
2400
Start Date
2026-07-22
Completion Date
2028-05-03
Last Updated
2026-10-14
Healthy Volunteers
Yes
Conditions
Interventions
RSV+HMPV vaccine
RSV + HMPV Candidate Vaccine
Control Vaccine 3
Control Vaccine 3
Control Vaccine 4
Control Vaccine 4
Control Vaccine 2
Control Vaccine 2
Placebo
Placebo
Control Vaccine 1
Control Vaccine 1
Locations (50)
Hawthorne Health - Gadsden- Site Number : 8400025
Gadsden, Alabama, United States
Accel Research Sites Network - Birmingham- Site Number : 8400065
Vestavia Hills, Alabama, United States
Marvel Clinical Research- Site Number : 8400006
Huntington Beach, California, United States
Velocity Clinical Research - San Diego- Site Number : 8400019
La Mesa, California, United States
Long Beach Research Institute- Site Number : 8400005
Long Beach, California, United States
Acclaim Clinical Research- Site Number : 8400033
San Diego, California, United States
Velocity Clinical Research - Washington DC- Site Number : 8400021
Washington D.C., District of Columbia, United States
Accel Research Sites Network - DeLand Clinical Research Unit- Site Number : 8400064
DeLand, Florida, United States
Velocity Clinical Research - New Smyrna Beach- Site Number : 8400017
Edgewater, Florida, United States
Accel Research Sites - Lakeland Clinical Research Unit- Site Number : 8400073
Lakeland, Florida, United States
Accel Research Sites - St. Petersburg - Largo- Site Number : 8400067
Largo, Florida, United States
Accel Research Sites - Maitland Clinical Research Unit- Site Number : 8400074
Maitland, Florida, United States
Alcanza - Innovation Medical Research Center - Palmetto- Site Number : 8400069
Palmetto Bay, Florida, United States
Accel Research Sites - NeuroStudies- Site Number : 8400063
Decatur, Georgia, United States
North Georgia Clinical Research- Site Number : 8400078
Woodstock, Georgia, United States
DM Clinical Research - Chicago- Site Number : 8400050
Melrose Park, Illinois, United States
Enspire Clinical Research- Site Number : 8400077
Peoria, Illinois, United States
DM Clinical Research - Indianapolis- Site Number : 8400082
Indianapolis, Indiana, United States
Velocity Clinical Research - New Orleans- Site Number : 8400022
New Orleans, Louisiana, United States
Boston Clinical Trials- Site Number : 8400070
Boston, Massachusetts, United States
DM Clinical Research - Brookline- Site Number : 8400055
Brookline, Massachusetts, United States
ActivMed Practices & Research - Methuen- Site Number : 8400066
Methuen, Massachusetts, United States
QUEST Research Institute- Site Number : 8400068
Farmington Hills, Michigan, United States
DM Clinical Research - Detroit- Site Number : 8400049
Southfield, Michigan, United States
Velocity Clinical Research - Lincoln - Valley Road- Site Number : 8400016
Lincoln, Nebraska, United States
Velocity Clinical Research - Omaha- Site Number : 8400012
Omaha, Nebraska, United States
Alliance Clinical - Las Vegas- Site Number : 8400034
Las Vegas, Nevada, United States
DM Clinical Research - New Jersey- Site Number : 8400044
Jersey City, New Jersey, United States
Hawthorne - Bienstar Lindenwold- Site Number : 8400027
Lindenwold, New Jersey, United States
DM Clinical Research - Albuquerque- Site Number : 8400051
Albuquerque, New Mexico, United States
Hawthorne Health - Staten Island- Site Number : 8400026
Staten Island, New York, United States
Velocity Clinical Research - Cleveland- Site Number : 8400024
Beachwood, Ohio, United States
Velocity Clinical Research - Springdale- Site Number : 8400014
Cincinnati, Ohio, United States
DM Clinical Research - Philadelphia- Site Number : 8400046
Philadelphia, Pennsylvania, United States
Velocity Clinical Research - Providence- Site Number : 8400018
East Greenwich, Rhode Island, United States
Coastal Carolina Research Center - North Charleston- Site Number : 8400061
North Charleston, South Carolina, United States
Velocity Clinical Research - Austin- Site Number : 8400013
Austin, Texas, United States
Zenos Clinical Research- Site Number : 8400032
Dallas, Texas, United States
DM Clinical Research - CyFair Clinical Research Center- Site Number : 8400058
Houston, Texas, United States
Texas Center for Drug Development - Houston- Site Number : 8400043
Houston, Texas, United States
DM Clinical Research - Dallas- Site Number : 8400059
Irving, Texas, United States
DM Clinical Research - San Antonio - North San Saba- Site Number : 8400056
San Antonio, Texas, United States
DM Clinical Research - San Antonio - North San Saba- Site Number : 8400057
San Antonio, Texas, United States
DM Clinical Research - Sugar Land- Site Number : 8400048
Sugar Land, Texas, United States
Olympus Clinical Research - Sugar Land- Site Number : 8400071
Sugar Land, Texas, United States
DM Clinical Research - Tomball- Site Number : 8400045
Tomball, Texas, United States
DM Clinical Research - Tomball- Site Number : 8400081
Tomball, Texas, United States
Charlottesville Medical Research- Site Number : 8400062
Charlottesville, Virginia, United States
Velocity Clinical Research - Hampton- Site Number : 8400015
Hampton, Virginia, United States
Dm Clinical - Seattle- Site Number : 8400047
Seattle, Washington, United States